BILL NUMBER: SB 1379 ENROLLED
BILL TEXT
PASSED THE SENATE AUGUST 31, 2006
PASSED THE ASSEMBLY AUGUST 29, 2006
AMENDED IN ASSEMBLY AUGUST 24, 2006
INTRODUCED BY Senators Perata and Ortiz
(Coauthor: Assembly Member Laird)
FEBRUARY 21, 2006
An act to add Chapter 8 (commencing with Section 105440) to Part 5
of Division 103 of the Health and Safety Code, relating to public
health.
LEGISLATIVE COUNSEL'S DIGEST
SB 1379, Perata Biomonitoring.
Existing law establishes various programs for the protection of
the public from exposure to toxins, including, but not limited to,
the Childhood Lead Poisoning Prevention Act, administered by the
State Department of Health Services, which imposes a fee upon
manufacturers or persons who are responsible for lead contamination
and applies the proceeds of the fee to reduction or elimination of
the harm caused by the lead contamination.
This bill would require the department in collaboration with the
California Environmental Protection Agency to establish the
California Environmental Contaminant Biomonitoring Program to monitor
the presence and concentration of designated chemicals, as defined,
in Californians.
This bill would require the department and the agency to establish
a Scientific Guidance Panel to assist the department and the agency.
The bill would require the department to provide public access to
information, and to report to the Legislature and the public.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. The Legislature finds and declares all of the
following:
(a) An estimated 100,000 chemicals are registered for use today in
the United States. Another 2,000 chemicals are added each year. Some
toxicological screening data exists for only 7 to 10 percent of
these chemicals. More than 90 percent of these chemicals have never
been tested for their effects on human health. Large numbers of these
chemicals are found in cosmetics, personal care products,
pesticides, food dyes, cleaning products, fuels, and plastics.
Because of their ubiquity in modern life, Californians are commonly
exposed to multiple chemicals every day. Many of these chemicals
persist in the environment, and accumulate and remain in body fat,
and have been shown to be toxic.
(b) Biomonitoring studies have scientifically demonstrated that
human exposure to a multitude of chemicals is widespread. The federal
Centers for Disease Control and Prevention has documented the
presence of 148 environmental chemicals in the blood and urine of
Americans of all ages and races.
(c) Biomonitoring studies will provide data that will help
California scientists, researchers, public health personnel, and
community members explore linkages between chemical exposures and
health.
(d) Biomonitoring data supports public health by establishing
trends in chemical exposures, validating modeling and survey methods,
supporting epidemiological studies, identifying highly exposed
communities, addressing the data gaps between chemical exposures and
specific health outcomes, informing health responses to unanticipated
emergency exposures, assessing the effectiveness of current
regulations, and helping to set priorities for reform.
(e) In September 2001, the Legislature passed Senate Bill 702
(Chapter 538, Statutes of 2001), making California the first state in
the nation to begin planning a statewide environmental health
tracking network for chronic diseases and environmental hazards and
exposures. To help implement the program, the Senate Bill 702 Expert
Working Group has recommended the establishment of a statewide
biomonitoring program.
(f) In September 2003, the Legislature passed Assembly Bill 1360
(Chapter 664, Statutes of 2003), that requires the development and
use in California of a comprehensive system of environmental
measurements known as environmental indicators. The basis for the
bill was the April 2002 report, "Environmental Protection Indicators
for California," by the California Environmental Protection Agency
and the Resources Agency. This report identifies biomonitoring as
part of an overall system of environmental indicators that California
should develop to guide policy and budgetary decisions.
(g) The Legislature, therefore, finds and declares that the
establishment of a statewide biomonitoring program will assist in the
evaluation of the presence of toxic chemicals in a representative
sample of Californians, establish trends in the levels of these
chemicals in Californians' bodies over time, and assess effectiveness
of public health efforts and regulatory programs to decrease
exposures of Californians to specific chemical contaminants. A
statewide and community-based biomonitoring program will expand
biomedical, epidemiological, and behavioral public health research.
California, an established leader in health promotion, health policy,
and health care delivery and response, should encourage and fund
this research, which will contribute to the health and well-being of
millions of people.
SEC. 2. Chapter 8 (commencing with Section 105440) is added to
Part 5 of Division 103 of the Health and Safety Code, to read:
CHAPTER 8. California Environmental Contaminant
Biomonitoring Program
Article 1. General
105440. (a) This chapter shall be known, and may be cited, as the
California Environmental Contaminant Biomonitoring Program.
(b) For the purposes of this chapter, the following terms have the
following meanings:
(1) "Agency" means the California Environmental Protection Agency.
(2) "Biomonitoring" means the process by which chemicals and their
metabolites are identified and measured within different biological
specimens.
(3) "Biological specimen" means a sample taken from a biophysical
substance, that is reasonably available within a human body, for use
as a medium to measure the presence and concentration of toxic
chemicals.
(4) "Community" means geographically or nongeographically based
populations that may participate in the community-based biomonitoring
program. A "nongeographical community" includes, but is not limited
to, populations that may share a common chemical exposure through
similar occupations, populations experiencing a common health outcome
that may be linked to chemical exposures, or populations that may
experience similar chemical exposures because of comparable
consumption, lifestyle, product use, or subpopulations that share
ethnicity, age, or gender.
(5) "Department" means the State Department of Health Services.
(6) "Designated chemicals" means those chemicals that are known
to, or strongly suspected of, adversely impacting human health or
development, based upon scientific, peer-reviewed animal, human, or
in vitro studies, and consist of only those substances including
chemical families or metabolites that are included in the federal
Centers for Disease Control and Prevention studies that are known
collectively as the National Reports on Human Exposure to
Environmental Chemicals program and any substances as specified
pursuant to subdivision (c) of Section 105449.
(7) "Director" means the Director of Health Services.
(8) "DTSC" means the Department of Toxic Substances Control within
the agency.
(9) "Office" means the Office of Environmental Health Hazard
Assessment within the agency.
(10) "Panel" means the Scientific Guidance Panel established
pursuant to Article 2 (commencing with Section 105448).
(11) "Program" or "biomonitoring program" means the California
Environmental Contaminant Biomonitoring Program, which shall be
established and operated by the department, in collaboration with the
agency, the office, and DTSC.
(12) "Secretary" means the Secretary of the California
Environmental Protection Agency.
105441. The department, in collaboration with the agency, shall
establish the California Environmental Contaminant Biomonitoring
Program. The department is the lead entity for the program unless
otherwise specified in this chapter. The program shall utilize
biological specimens, as appropriate, to identify designated
chemicals that are present in the bodies of Californians.
Biomonitoring shall utilize scientifically based statewide surveys.
Additional community-based surveys shall be contingent on funding and
shall be statistically valid and scientifically based.
Biomonitoring shall take place on a strictly voluntary and
confidential basis. Results reported pursuant to this chapter shall
not disclose individual confidential information of participants.
Appropriate biological specimens shall be used to monitor and assess
the presence and concentration of designated chemicals. Biological
specimens shall be analyzed by laboratories operated by the
department, DTSC, or their contractors.
105443. (a) All participants shall be evaluated for the presence
of designated chemicals as a component of the biomonitoring process.
Participants shall be provided with information and fact sheets about
the program's activities and its findings. Individual participants
may request and shall receive their complete results. Any results
provided to participants shall be subject to the Institutional Review
Board protocols and guidelines. When either physiological or
chemical data obtained from a participant indicate a significant
known health risk, program staff experienced in communicating
biomonitoring results shall consult with the individual and recommend
followup steps, as appropriate. Program administrators shall receive
training in administering the program in an ethical, culturally
sensitive, participatory, and community-based manner.
(b) Individuals selected to participate in the biomonitoring
program shall reflect the age, economic, racial, and ethnic
composition of the state. Other selection criteria may be applied, as
appropriate, for studies of specific populations.
(c) Informational materials and outreach activities directed to
program participants and communities shall, to the extent possible,
be culturally appropriate and translated as needed. Educational
materials shall be adapted to the biological specimens being used.
105444. (a) The program shall develop guidelines and model
protocols that address the science and practice of biomonitoring to
implement this chapter, including, but not limited to, study design,
subject recruitment, and data collection and management, and that
accomplish all of the following:
(1) Ensure confidentiality and informed consent.
(2) Communicate findings to participants, communities, and the
general public.
(3) Emphasize all aspects of the program in a culturally sensitive
manner.
(4) Serve as a guide for other biomonitoring programs supported by
state funds.
(b) The program shall incorporate, as appropriate, the methods
utilized by the federal Centers for Disease Control and Prevention
for the studies known collectively as the National Report on Human
Exposure to Environmental Chemicals.
(c) The program shall be implemented in collaboration with the
California Environmental Health Tracking Program and the
environmental indicators system maintained by the office pursuant to
Section 71081 of the Public Resources Code.
(d) The department, office, and DTSC shall collaborate on the
development of fact sheets and other informational and outreach
materials for the biomonitoring program.
(e) The department, in collaboration with the office and DTSC,
shall conduct statistical and epidemiological analyses of the
biomonitoring results.
(f) Personal information as defined in Section 1798.3 of the Civil
Code, shall not be shared without the written and informed consent
of the individual to whom it pertains.
(g) No governmental agency or private person or entity shall
discriminate against a person or community based upon the
biomonitoring results.
Article 2. The Scientific Guidance Panel
105448. (a) In implementing the program, the department and the
agency shall establish a Scientific Guidance Panel. The panel shall
be composed of nine members, whose expertise shall encompass the
disciplines of public health, epidemiology, biostatistics,
environmental medicine, risk analysis, exposure assessment,
developmental biology, laboratory sciences, bioethics, maternal and
child health with a specialty in breastfeeding, and toxicology.
(b) The Governor shall appoint five members to the panel, the
Senate Committee on Rules shall appoint two members, and the Speaker
of the Assembly shall appoint two members. The appointments shall be
made after soliciting recommendations of the Office of the President
of the University of California.
(c) All members shall be appointed to the panel by September 1,
2007. Members shall be appointed for three-year terms, except that,
with respect to the initial appointees each appointing power shall
appoint one member for a one-year term and one member for a two-year
term. Members may be reappointed for additional terms without
limitation.
(d) The panel shall meet as often as it deems necessary, with
consideration of available resources, but at a minimum, three times
per year. The office shall be responsible for staffing and
administration of the panel.
(e) The panel meetings shall be open to the public and be subject
to the Bagley-Keene Open Meetings Act (Article 9 (commencing with
Section 11120) of Part 1 of Division 3 of Title 2 of the Government
Code).
(f) Members of the panel shall be reimbursed for travel and other
necessary expenses incurred in the performance of their duties under
this chapter, but shall not receive a salary or compensation.
105449. (a) The panel shall provide scientific peer review and
make recommendations regarding the design and implementation of the
program, including specific recommendations for chemicals that are
priorities for biomonitoring in California, as specified in
subdivisions (b) and (c), with the program retaining final
decisionmaking authority.
(b) The panel shall recommend priority chemicals for inclusion in
the program using the following criteria:
(1) The degree of potential exposure to the public or specific
subgroups, including, but not limited to, occupational.
(2) The likelihood of a chemical being a carcinogen or toxicant
based on peer-reviewed health data, the chemical structure, or the
toxicology of chemically related compounds.
(3) The limits of laboratory detection for the chemical, including
the ability to detect the chemical at low enough levels that could
be expected in the general population.
(4) Other criteria that the panel may agree to.
(c) The panel may recommend additional designated chemicals not
included in the CDC report, for inclusion in the program using the
following criteria:
(1) Exposure or potential exposure to the public or specific
subgroups.
(2) The known or suspected health effects resulting from some
level of exposure based on peer-reviewed scientific studies.
(3) The need to assess the efficacy of public health actions to
reduce exposure to a chemical.
(4) The availability of a biomonitoring analytical method with
adequate accuracy, precision, sensitivity, specificity, and speed.
(5) The availability of adequate biospecimen samples.
(6) The incremental analytical cost to perform the biomonitoring
analysis for the chemical.
105451. (a) As appropriate, the program shall utilize the
principles of the agency's Environmental Justice Strategy and
Environmental Justice Action Plan developed pursuant to Sections
71110 to 71113, inclusive, of the Public Resources Code, so that the
activities of the panel and the implementation of the program provide
opportunities for public participation and community capacity
building with meaningful stakeholder input. This strategy and plan
shall accord the highest respect and value to every individual and
community by developing and conducting public health and
environmental protection programs, policies, and activities in a
manner that promotes equity and affords fair treatment,
accessibility, and protection for all Californians, regardless of
race, age, culture, income, or geographic location.
(b) (1) To carry out this section, the program shall develop a
strategy and plan that are to be followed in the implementation of
the program. This strategy and plan shall be used to establish the
framework for integrating public participation in this program. The
department may utilize models used by boards, departments, and
offices at the agency for community outreach pursuant to this
section.
(2) Public participation shall include, but need not be limited
to, conducting stakeholder meetings and workshops to solicit relevant
information, data, suggestions, and feedback for the development and
implementation of the program.
Article 3. Fiscal Provisions
105453. Implementation of this chapter shall be contingent on a
specific appropriation being provided for this purpose in the annual
Budget Act or other measure.
Article 4. Reporting
105459. (a) By January 1, 2010, and every two years thereafter,
the department, in collaboration with the agency, the office, and
DTSC, shall submit a report to the Legislature containing the
findings of the program, and shall include in the report additional
activities and recommendations for improving the program based upon
activities and findings to date. Copies of the report shall be made
available via appropriate media to the public within 30 calendar days
following its submission to the Legislature.
(b) The department shall provide the public access to information
which they are required to release pursuant to the California Public
Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7
of Title 1 of the Government Code).
(c) The department and the office shall disseminate biomonitoring
findings to the general public via appropriate media, including
governmental and other Web sites in a manner that is understandable
to the average person.
(d) Any health and environmental exposure data made available to
the general public shall be provided in a summary format to protect
the confidentiality of program participants. The data shall be made
available, after appropriate quality assurance and quality control,
by July 1, 2010, and at least every two years thereafter.